A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test

Completed · Not applicable

Conditions studied: Sleep Apnea

In brief

The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.

Key facts

Study ID

NCT04191668

Run by

Ectosense NV

People needed

106

Starts

2019-12-02

Expected to finish

2020-02-01

Last updated by the study team

2021-03-30

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects with an indication for an in-lab polysomnography

You may not qualify if…

• Intellectually disabled people
• People younger than 13 years of age.

Where it is running

• Miami Lakes Laboratory — Miami Lakes, Florida, United States
• Plantation Laboratory East — Plantation, Florida, United States
• Plantation Laboratory West — Plantation, Florida, United States

Full record on ClinicalTrials.gov

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